1. Field of the Disclosure
The present invention relates to methods, compositions and kits for treating frequent headaches. More particularly, this invention is concerned with alleviating frequent headache by intranasal administration of a local anesthetic together with a non-steroidal anti-inflammatory drug that blocks the formation of prostaglandin.
2. Discussion of the Background
A headache is a very common, recurring condition that is characterized by pain anywhere in the head or the neck. This disorder affects millions of Americans daily. The term “headache” includes migraines, cluster headaches, tension headaches, trigeminal neuralgia, cranial neuralgia and facial pain.
Infrequent headaches are commonly treated with oral administration of analgesics such as acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs). However, frequent or recurrent headaches have numerous causes and in most cases it is very difficult to determine. Oral administration of analgesics is not an effective way to treat frequent or recurrent headaches. Furthermore, the prolonged use of analgesics can be detrimental to the health of the patient. For instance, NSAIDs relate to adverse effect in the gastrointestinal and/or renal system of the patient. Also, daily use of analgesics can perpetuate the headache disorder. Thus the overuse of analgesics can be itself the cause of headaches. Generally analgesics should not be used for more than 15 days per month.
Methods for the treatment of recurrent headaches include: yoga, hypnosis, relaxation treatments, meditation, amongst others. However in many cases these treatments turn out to be unsuccessful. Also most of the patients that suffer from frequent headaches spent a significant amount of money and time trying to determine the cause of the headaches with different studies such as radiographies, brain scan, magnetic resonance, electroencephalography, amongst others, without any success.
An alternative treatment for headaches is a process called Sphenopalatine Ganglion Block (SPGB). The first SPGB was reported by Greenfield Sluder in which the process consisted in a transnasal administration of a cotton-tipped applicator dipped in 90% watery solution of cocaine hydrochlorate for a period of five minutes into the sphenopalatine ganglion.
The sphenopalatine ganglion, also known as Meckel's ganglion, is located in the pterygopalatine fossa, posterior to the middle nasal turbinate under a 1-1.5 mm layer of connective tissue and mucous membrane and anterior to the pterygoid canal. The sphenopalatine ganglion comprises the largest cluster of sympathetic neurons in the head outside of the brain. It also has major branches to the trigeminal nerve, the facial nerve, the carotid plexus and the superior cervical ganglion.
It is understood that the sphenopalatine ganglion serves as an important way of transmission of pain. The SPGB consists in stopping the nerve impulses of the sphenopalatine ganglion by administering a local anesthetic. This type of treatment may be referred to as a nerve block.
Additionally, other conditions or diseases such as headache disorders and other neurological conditions can be arrested, or improved by local anesthetic blockade, and/or other pharmacological augmentation or mechanical alteration of the sphenopalatine ganglion and surrounding structures.
The first SPGB performed by Sluder used cocaine as the local anesthetic. Over time, some other anesthetics have been used instead of cocaine to perform the SPGB. For instance, U.S. Pat. No. 4,886,493 discloses an SEGE using lidocaine, a shorter-acting local anesthetic. However, U.S. Pat. No. 6,432,986 discloses that the use of a shorter-acting local anesthetic such as lidocaine merely decreases head pain for a period equal to the duration of the analgesia which is a approximately less than an hour. U.S. Pat. No. 6,432,986 discloses an SPGB using long-acting local anesthetics such as ropivacaine or bupivacaine which provides anesthesia to the nerve structure for at least about an hour. U.S. Pat. No. 6,432,986 posits that these long-acting local anesthetics provide head pain relief even after the period of anesthesia.
However, the frequency of recurrence or rebound continues to be a major problem within the art. A significant number of patients continue to have recurrent headaches after been treated with an SPGB using long-acting local anesthetics. The frequency of recurrence could be a few hours or days. Thus, there is still a need to provide a composition which reduces the frequency of recurrence or rebound.